Medicaments for treating colics

ABSTRACT

A medicament for use in treating babies suffering from colic. The medicament comprises diphenhydramine hydrocloride (HCl), belladonna tincture, a buffer, flavorants, such as sweetener and absolute alcohol. The medicament is treated by gamma ray bombardment or having a preservative incorporated therein for increasing the medicament&#39;s shelft life. The medicament is preferably orally fed to an infant in a dose of 1 ml per kilogram of the infant&#39;s body mass, a maximum dose being 8 ml, and at about four times per hour.

FIELD OF THE INVENTION

This invention relates to medicaments. More particularly, the presentinvention relates to the treatment of colics in infants.

DESCRIPTION OF THE PRIOR ART

The invention is concerned with medicaments for use in treating babiesand in particular to treating babies suffering from colic. Colic is avery widespread illness suffered by babies usually under three to fourmonths of age. Infantile colic is a syndrome characterised byparoxysmal, excessive, and inconsolable crying without identifiablecause in a healthy infant. It is also called persistent crying ininfancy and 3-month colic. The behaviour of colicky infants is a causeof anxiety and worry to their parents. Many medicaments for treatingthis source of discomfort in babies have been proposed but none, to ourknowledge is wholly satisfactory.

SUMMARY OF THE INVENTION

According to one aspect of the invention there is provided a medicamentfor treating colic comprising diphenhydramine HCl, belladonna tincture,a buffer and flavourants as well as absolute alcohol and has beentreated to increase shelf life, wherein the alcohol constituentcomprises between 2.8% and 3.2%, and preferably 3.2% by volume of themedicament. Where the alcohol is a dilute form of alcohol e.g. alcoholBP 96.4% the amount of that dilute alcohol may be increased so that theactual alcohol content is as mentioned. Conveniently the buffer iscitric acid.

DETAILED DESCRIPTION OF THE INVENTION

The medicament may be treated to increase shelf life by being bombardedby gamma rays. Alternatively and more usually the medicament is treatedto increase shelf life by incorporating a preservative as a constituent.This preservative may comprise one or more of the following, viz methylparaben, propyl paraben, aqueous chloroform, preferably in concentrateform, and alcohol and conveniently all of these ingredients. Anotherpreservative which may be used is sodium benzoate. The alcohol inaddition to being a preservative is also the solvent for the medicament.The methyl paraben conveniently comprises between 50 to 100 gm andpreferably 100 gm per 100 l medicament. The propyl paraben convenientlycomprises between 5 to 10 gm and preferably 10 gm per 100 l medicament.

The flavourant is preferably a sweetener. The sweetener may be acyclamate or saccharine. Preferably however it comprises a berry,preferably raspberry, flavourant which conveniently comprises of theorder of 50 ml per 100 l medicament. The sweetener may further oralternatively include syrup simplex which may conveniently comprisebetween 20 to 35 l and preferably 35 l per 100 l medicament.

The aqueous chloroform concentrate also serves as a preservative.

It will also be understood that the assqeous chloroform concentrate andbelladonna tincture contain alcohol. The total amount of alcohol in themedicament is conveniently between 4.75% to 5.1% preferably about 5.1%.Accordingly another aspect of the invention provides a medicament fortreating colic comprising diphenhydramine HCl, belladonna tincture, abuffer and flavourants and aqueous chloroform concentrate as well asabsolute alcohol and has been treated to increase shelf life, whereinthe alcohol content of the medicament comprises between 4.75% and 5.1%,and preferably 5.1% by volume of the medicament.

According to a further aspect of the invention there is provided amethod of treating a colicky infant comprises feeding the infant amedicament as mentioned in any one of the preceding claims. Themedicament is preferably administered to the infant in an amount of theof 1 ml per kilogram body mass with feeds normally four hourly with amaximum of 8 ml per dose.

An example of the medicament is given below, with the amounts set forthboth for a single dosage amount and for the amounts for making 100 l.The names of the suppliers is given for identification purposes only.The ingredients may be supplied by others.

Constituent Purpose Supplier Per 5 ml Per 100 l Diphenhydramine HClActive Sweizerhall 3.125 mg 62.5 g Belladonna Tincture Active WilliamRansome 0.125 ml 2.5 l Absolute alcohol 99% Solvent Illovo 0.16 ml 3.2 lCitric acid monohydrate Buffer Medicolab 6.25 mg 125 g aqueouschloroform concentrate Flavourant Medicolab 0.025 ml 0.5 l methylparaben Preservative Ethnichem 5 mg 100 g propyl paraben PreservativeProtameen Chem 0.5 mg 10 g syrup simplex Sweetener Bush Boake Allen 1.75ml 35 l Raspberry Flavour Sweetener Bush Boake Allen 0.0025 mg 0.050 lPoncho 4R Colourant Bush Boake Allen 0.27 mg 5.4 g Distilled WaterSolvent Medicolab to 5 ml to 100 l

The total alcohol content of this example is approximately 5.1% byvolume of the medicament. This is calculated as follows:

Absolute alcohol 0.16 ml × 99% = 0.1584 ml Aq Chlorof. Conc 0.025 ml ×(60% × 90%) =  0.135 ml Belladona Tinc 0.125 ml × 65% = 0.0813 ml 0.2553ml 0.2553 ml/5 ml = 5.066%.

Instead of using absolute alcohol, alcohol BP 94.4% may be used in whichcase a slightly greater amount may be used to have the same effect asabsolute alcohol.

We have found that the raspberry flavoured sweetener is mostsatisfactory and also provides [in addition] a pleasant fragrance to themedicament. However other flavoured sweeteners may be used such asstrawberry sweetener.

All the ingredients used are as approved by the Medical Control Councilof South Africa.

In tests carried out, it was found that about 77% of the patients showedmoderate or excellent improvement when treated with the abovemedicament. Babies had high tolerance for the medicament. Only about 11%of the babies experienced adverse events regarded as possibly related tothe medicament. The most affected body system was in the digestivesystem where constipation was caused. In addition we have found thatexcess nasal mucous has in a few cases been noted. These adverse eventswere mild to moderate in intensity. Most of the adverse events wereresolved within a short time.

Care should be exercised in using the medicament in cases where the babysuffers from epilepsy or asthma or there is a family history of theseillnesses.

The medicament may be altered as will be appreciated by those skilled inthe art. However the alcohol content should not be increased above thatmentioned above.

What has been described above are preferred aspects of the presentinvention. It is of course not possible to describe every conceivablecombination of components or methodologies for purposes of describingthe present invention, but one of ordinary skill in the art willrecognize that many further combinations and permutations of the presentinvention are possible. Accordingly, the present invention is intendedto embrace all such alterations, combinations, modifications, andvariations that fall withing the spirit and scope of the appendedclaims.

1. A medicament for treating colic comprising diphenhydramine HCl,belladonna tincture, a buffer and flavourants as well as absolutealcohol and has been treated to increase shelf life, wherein the alcoholconcentrate comprises between 2.8% and 3.2% by volume of the medicament.2. A medicament as claimed in claim 1 wherein the alcohol is 3.2% byvolume of the medicament.
 3. A medicament as claimed in claim 1 whereinthe buffer is citric acid.
 4. A medicament as claimed in claim 1 whereinthe medicament is treated to increase shelf life by being bombarded bygamma rays.
 5. A medicament as claimed in claim 1 wherein the medicamentis treated to increase shelf life by incorporating a preservative as aconstituent.
 6. A medicament as claimed in claim 5 wherein thepreservative is at least one selected from the group consisting of vizmethyl paraben, propyl paraben, aqueous chloroform and alcohol.
 7. Amedicament as claimed in claim 6 wherein the methyl paraben is in amountof 50 to 100 gm per 100 l medicament.
 8. A medicament as claimed inclaim 7 wherein the methyl paraben is in an amount of 100 gm per 100liter medicament.
 9. A medicament as claimed in claim 6 wherein thepropyl paraben is in an amount of 5 to 10 gm per 100 liter medicament.10. A medicament as claimed in claim 9 wherein the propyl paraben is inan amount of 10 gm per 1001 medicament.
 11. A medicament as claimed inclaim 1 wherein the flavourant is a sweetener.
 12. A medicament asclaimed in claim 11 wherein the sweetener is a berry flavourant.
 13. Amedicament as claimed in claim 11 wherein the sweetener includes syrupsimplex.
 14. A medicament as claimed in claim 13 wherein the syrup is anamount of 20 to 35 liter per 100 liter medicament.
 15. A medicament asclaimed in claim 14 wherein the syrup is an amount of 35 liter per 100liter medicament.
 16. A medicament for treating colic comprisingdiphenhydramine HCl, belladonna tincture, a buffer and flavourants andaqueous chloroform concentrate as well as absolute alcohol and has beentreated to increase shelf life, wherein the alcohol content of themedicament comprises between 4.75% and 5.1% by volume of the medicament.17. A medicament as claimed in claim 16 wherein the alcohol content ofthe medicament comprises 5.1% by volume of the medicament.
 18. Themedicament according to claim 12 wherein the berry flavourant is araspberry flavourant.
 19. The medicament according to claim 18 whereinthe raspberry flavourant is an amount of 50 ml per 100 liter ofmedicament.
 20. A medicament for a treating colic comprisingdiphenhydramine ACl, belladona tincture, a buffer, a flavorant, and asolvent selected from the group consisting of absolute alcohol, glycol,sorbitol and glycerine.
 21. The medicament according to claim 20 whereinthe medicament is treated to increase shelf life, said treatmentselected from the group consisting of gamma ray bombardment andincorporating a preservative as a constituent in said medicament. 22.The medicament according to claim 21 wherein the preservative is atleast one selected from the group consisting of alcohol, propyleneglycol, sorbitol, glycerine, viz methyl paraben, propyl paraben, sodiumbenzoate an aqueous chloroform.
 23. The medicament according to claim 22wherein the alcohol is absolute alcohol.
 24. The medicament according toclaim 20, wherein the solvent is absolute alcohol.
 25. A method oftreating a colicky infant comprising the steps of: preparing amedicament comprising: diphenhydramine HCl; belladona tincture; abuffer; a flavourant; and absolute alcohol, wherein the alcohol isbetween 2.8% and 3.2% the volume of the medicament; treating saidmedicament for increased shelft life; and orally administering saidmedicament to the colicky infant in a dosage of 1 ml per kilogram ofinfant body mass.
 26. A method as claimed in claim 25 wherein themedicament is supplied to the infant in an amount of 1 ml per kilogrambody mass.
 27. A method according to claim 25 wherein the dosage doesnot exceed 8 ml.
 28. A method according to claim 25 wherein the dosageis administered once every four hours.